Xi Junyu, Wei Ruili, Cui Xin, Liu Yi, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Front Pharmacol. 2023 Apr 7;14:1074400. doi: 10.3389/fphar.2023.1074400. eCollection 2023.
Xueshuantong (lyophilized) for injection (XST) is an effective botanical drug for treating unstable angina pectoris (UAP). However, a meta-analysis of XST combined with conventional treatment (CT) against UAP has not been conducted. Therefore, this study aimed to investigate the effectiveness and safety of XST combined with CT for UAP patients compared to CT alone. Randomized controlled trials (RCT) of XST in UAP patients were retrieved from the Cochrane Library, PubMed, Web of Science, EMBASE, CNKI, VIP, Wanfang, and Chinese Biological Medicine Database databases. A meta-analysis was performed using Revman 5.4 and Stata 16.0, and the quality of the included literature was evaluated based on the Cochrane risk-of-bias 2.0 (RoB2.0) tool. The aggregate 95% confidence intervals (CIs), mean difference (MD), and relative risk (RR) estimates were calculated. A GRADE assessment was performed using GRADEprofiler 3.6, and trial sequent analysis was performed using TSA 0.9. Thirty-four studies involving 3,518 patients were included in the analysis. The combination of CT with XST improved the comprehensive clinical efficacy (RR = 1.22, 95% CI: 1.18-1.26, < 0.00001) and ECG improvement (RR = 1.24, 95% CI: 1.18-1.31, < 0.00001). The frequency of angina attacks was lower (MD = -0.73, 95% CI: -0.92 to -0.55, < 0.00001), and the duration was shorter (MD = -1.08, 95% CI: -1.44 to -0.72, < 0.00001) in the group that received CT combined with XST compared to the one without XST. Total cholesterol levels (MD = -1.30, 95% CI: -1.83 to -0.78, < 0.00001) and triglyceride levels (MD = -0.76, 95% CI: -0.93 to -0.59, < 0.00001) were lower in patients who received CT in combination with XST than those who received CT alone. CT combined with XST reduced whole blood viscosity (MD = -0.72, 95% CI = -0.99 to -0.44, < 0.00001) and plasma viscosity (MD = -0.24, 95% CI: -0.46 to -0.03, = 0.03). There was no statistically significant difference in the incidence of cardiovascular events or adverse events among patients treated with the combination of XST and CT compared to CT alone. The GRADE assessment indicated that the composite quality of the evidence was low. The trial sequent analysis showed an adequate sample size and stable findings for the clinical efficacy of CT combined with XST for unstable angina. The present systematic review and meta-analysis conditionally indicate that XST combined with CT improved the clinical outcomes of patients with unstable angina more than CT alone with a better safety profile. However, the results need further validation due to limitations in the quality of the included studies. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022357395.
注射用血栓通（冻干）（XST）是治疗不稳定型心绞痛（UAP）的一种有效植物药。然而，尚未对XST联合常规治疗（CT）针对UAP进行荟萃分析。因此，本研究旨在探讨与单纯CT相比，XST联合CT治疗UAP患者的有效性和安全性。从Cochrane图书馆、PubMed、科学网、EMBASE、中国知网、维普、万方和中国生物医学数据库中检索UAP患者使用XST的随机对照试验（RCT）。使用Revman 5.4和Stata 16.0进行荟萃分析，并根据Cochrane偏倚风险2.0（RoB2.0）工具评估纳入文献的质量。计算汇总95%置信区间（CI）、平均差（MD）和相对风险（RR）估计值。使用GRADEprofiler 3.6进行GRADE评估，并使用TSA 0.9进行试验序贯分析。分析纳入了34项研究，涉及3518例患者。CT联合XST改善了综合临床疗效（RR = 1.22，95%CI：1.18 - 1.26，<0.00001）和心电图改善情况（RR = 1.24，95%CI：1.18 - 1.31，<0.00001）。与未使用XST的组相比，接受CT联合XST治疗的组心绞痛发作频率更低（MD = -0.73，95%CI：-0.92至-0.55，<0.00001），发作持续时间更短（MD = -1.08，95%CI：-1.44至-0.72，<0.00001）。接受CT联合XST治疗的患者总胆固醇水平（MD = -1.30，95%CI：-1.83至-0.78，<0.00001）和甘油三酯水平（MD = -0.76，95%CI：-0.93至-0.59，<0.00001）低于单纯接受CT治疗的患者。CT联合XST降低了全血粘度（MD = -0.72，95%CI = -0.99至-0.44，<0.00001）和血浆粘度（MD = -0.24，95%CI：-0.46至-0.03，=0.03）。与单纯CT治疗相比，XST联合CT治疗的患者心血管事件或不良事件发生率无统计学显著差异。GRADE评估表明证据的综合质量较低。试验序贯分析显示样本量充足，且CT联合XST治疗不稳定型心绞痛的临床疗效结果稳定。本系统评价和荟萃分析有条件地表明，与单纯CT相比，XST联合CT能更好地改善不稳定型心绞痛患者的临床结局，且安全性更好。然而，由于纳入研究质量的局限性，结果需要进一步验证。https://www.crd.york.ac.uk/PROSPERO/，标识符CRD42022357395 。
